Healthy ParticipantsPhase 1NCT06380205
A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females
A Phase 1 study testing Povorcitinib and Levonorgestrel/Ethinyl estradiol in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Povorcitinib and Levonorgestrel/Ethinyl estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 7 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Females aged 18 to 60 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 30.5 kg/m2, inclusive.
- No clinically significant findings in screening evaluations (eg, clinical, laboratory, and ECG evaluations).
- Ability to swallow and retain oral medication.
Who cannot join
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months before screening.
- Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect drug absorption.
- Current or recent (within 3 months before screening) clinically significant gastrointestinal disease (eg, gallbladder disease) or surgery (including cholecystectomy; excluding appendectomy) that could affect the absorption of study treatment.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease (eg, deep vein thrombosis), pulmonary embolism, or uncontrolled hypertension (ie, blood pressure > 140/90 mmHg at screening, confirmed by repeat testing).
- Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
- History of tobacco- or nicotine-containing product-use within 1 month before screening.
- Pregnant, breastfeeding, or planning to conceive during the study.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Celerion Clinical Research Unit
Tempe, Arizona, 85283
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females
The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females.
- Conditions
- Healthy Participants
- Being tested
- Povorcitinib, Levonorgestrel/Ethinyl estradiol
- Keywords
- INCB054707
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovorcitinibDrug
Also called INCB054707
Povorcitinib will be administered at protocol defined dose.
Levonorgestrel/Ethinyl estradiolDrug
Levonorgestrel/Ethinyl estradiol will be administered at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE) | Experimental | Povorcitinib and LNG/EE will be administered at the protocol defined doses. Receives: Drug: Povorcitinib; Drug: Levonorgestrel/Ethinyl estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levonorgestrel (LNG) concentration in plasma
LNG concentration in plasma.
Measured: Up to Day 21
Ethinyl estradiol (EE) concentration in plasma
EE concentration in plasma.
Measured: Up to Day 21
Secondary outcomes (3)
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment.
Measured: Up to Day 32
Additional LNG/EE PK parameters in plasma
Additional LNG/EE PK parameters in plasma.
Measured: Up to Day 21
Povorcitinib concentration in plasma
Povorcitinib concentration in plasma.
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start7 May 2024
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380205
- Sponsor's protocol ID
- INCB54707-111
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females
- ClinicalTrials.gov ID
- NCT06380205
- Acronym / sponsor ID
- INCB54707-111
- Conditions
- Healthy Participants
- Keywords
- INCB054707
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE) | Experimental | Drug: Povorcitinib, Drug: Levonorgestrel/Ethinyl estradiolPovorcitinib and LNG/EE will be administered at the protocol defined doses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Females aged 18 to 60 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 30.5 kg/m2, inclusive.
- No clinically significant findings in screening evaluations (eg, clinical, laboratory, and ECG evaluations).
- Ability to swallow and retain oral medication.
Key exclusion criteria (8 listed)
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months before screening.
- Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect drug absorption.
- Current or recent (within 3 months before screening) clinically significant gastrointestinal disease (eg, gallbladder disease) or surgery (including cholecystectomy; excluding appendectomy) that could affect the absorption of study treatment.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease (eg, deep vein thrombosis), pulmonary embolism, or uncontrolled hypertension (ie, blood pressure > 140/90 mmHg at screening, confirmed by repeat testing).
- Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PovorcitinibAlso: INCB054707Povorcitinib will be administered at protocol defined dose. | Drug | Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE) |
| Levonorgestrel/Ethinyl estradiolLevonorgestrel/Ethinyl estradiol will be administered at protocol defined dose. | Drug | Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE) |
Primary outcome
Levonorgestrel (LNG) concentration in plasma
Time frame: Up to Day 21
LNG concentration in plasma.
Ethinyl estradiol (EE) concentration in plasma
Time frame: Up to Day 21
EE concentration in plasma.
3 secondary outcomes
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 32
Additional LNG/EE PK parameters in plasma
Time frame: Up to Day 21
Povorcitinib concentration in plasma
Time frame: Up to Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Povorcitinib and Levonorgestrel/Ethinyl estradiol in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levonorgestrel (LNG) concentration in plasma (time frame: Up to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.